System and method for administering medicaments to a patient

ABSTRACT

The invention relates to a system and method for administering medicaments to a patient. The system comprises: a mobile medicament container with a liquid medicament; an identification-element-generating device for generating a first identification element with first data relating to the patient, medication and/or treatment, in order to apply this identification element to the medicament container; a reading device for reading the first data; a delivery device for delivering the medicament to the patient from the medicament container inserted into the delivery device, wherein the reading device is suitable for reading second data provided on/in a second identification element assigned to the patient and connected to the delivery device, and a control device within the delivery device sends a first control signal for activating the delivery process to at least one of a plurality of delivery units of the delivery device if the first and second data at least partially match.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a U.S. National Stage Application under 35 U.S.C.§371 of International Application No. PCT/EP2011/053246, filed Mar. 3,2011, which claims the benefit of German Application Nos. 10 2010 010567.8, filed Mar. 5, 2010, and 10 201 0 012 733.7, filed Mar. 24, 2010.

DESCRIPTION

The invention relates to a system and a method for administeringmedicaments to a patient.

It is known that patients, in particular in intensive care, are suppliedwith medicaments and possibly artificial food by means of one or moresupply devices, for example intravenously or by means of a feeding tube.For example, the supply device can be an insulin supply device or aninfusion pump which keeps the insulin value present inside thebloodstream of the patient at a pre-determinable level in reaction to apreviously measured blood glucose value in the bloodstream of thepatient. In the same way, supply devices for at least one nutritionalvalue of a food supplied to the bloodstream directly or indirectly by atleast one food supply device can be administered to the patient.

Supply devices of this type have in common the fact that, even if theyare integrated into a system for administering medicaments and/ornutritional values, they require the entering of values which are basedupon supply by means of the supply device to be carried out by a doctoror a further clinical member of staff. For example, quantity values,time intervals in which the supply is to be carried out, intermittentsupplies etc. can be entered here as a basis for the supply of insulinfor example which is to be subsequently carried out.

Prior to this supply a blood sample is taken from the patient, which isusually carried out by hand and which requires the intervention ofclinical staff. In the same way, further clinical staff are required whohave the necessary specialist knowledge for the entry functions of thesupply device, such as the infusion pump, in order to carry out thissupply subsequently.

In addition, supply devices of this type, such as infusion pumps, have afeed rate which is indicated in the form of volume per unit of time(ml/h). In contrast, the dosage unit is used in medicine for a suppliedmedicament solution. Consequently it is necessary for the dosage unit tobe converted into a feed rate of the pump, which is the task of theattending doctor. A disadvantage of a conversion of this type can befrequent calculation errors, which lead to erroneous entries of the feedrate and thus to an incorrect administration of insulin to the patient.

It is also imaginable to make it possible to enter the dosage unit in aninfusion pump. This, however, makes it necessary to take intoconsideration information on the concentration of the active material ofthe medicament to be administered and on the nature of the medicament.Until now, only the main active materials of the medicament have beentaken into consideration both in the information on the concentration ofthe active material and in the entry of the dosage unit and theconversion thereof into the feed rate. This is frequently sufficient ifonly or primarily one specific medicament is to be administered.

Supply devices or feed apparatus for the supply of a medicament solutionmixture into a body are known in a multiplicity of forms. For example,apparatus/systems with a plurality of infusion and/or injection pumpsare known, each of which supplies a solution with at least one specificactive material of a medicament to a body and, as a result, a medicamentsolution mixture is formed.

Infusion pump systems of this type are frequently used in the case ofpatients who require an intensive medical treatment. In this case theinfusion pumps have the property of continuous precise dosing of themedication in their supply. In order to achieve an optimum adjustment ofthese pumps in their dosing, the pumps are integrated in a commonclassification system which usually has a central control unit, anoperating unit and an alarming unit. During the conveying of alreadyprepared medicaments, which can be present inside a syringe for example,to the actual infusion pump there is frequently the risk that confusionmay arise with respect to the medicament dosage and the patient. Forexample it is possible for syringes of this type with medicaments of apre-determined dose contained in them to be allocated to the wronginfusion pump by the clinical staff and thus to be administered to thewrong patient. The result of this is that a patient receives the wrongmedicament and/or the wrong dose or dosage. Problems of this type occurin particular when a large number of patients is supplied withmedicaments for their infusion pumps by the attending person and so alarge number of infusion pumps with medicament syringes have to besupplied from a central medicament preparation station. In particular,in conjunction with a blood analysis device which is frequently presentas a common analysis device for a large number of patients whose bloodis to be analysed, there is a risk of confusion of the medicamentsresulting from the performed blood analysis in the respective syringesduring the transfer to the respective infusion pumps and the patientassociated with them.

Consequently the object of the invention is to make available a systemand a method for administering medicaments to a large number of patientswhich makes available a high degree of reliability in the allocation ofthe correct medicament to the respective patient and his or her supplydevice.

This object is attained with respect to the system by the features ofclaim 1 and with respect to the method by the features of claim 8.

The key concept of the invention is that in a system for administeringmedicaments to a large number of patients, in particular to a selectedpatient, the following features are present:

at least one mobile medicament container with at least one liquidmedicament;

an identification element production device for producing at least onefirst identification element with first data relating to the person,medicament and/or treatment in order to attach them to the medicamentcontainer;

at least one reading device for reading the first data from or out ofthe first identification element;

a supply device for supplying the medicament from the medicamentcontainer inserted in the supply device to the patient;

the reading device likewise being suitable for reading second data,which are attached to or in a second identification element which isallocated to the patient, and being connected to the supply device, and

a control unit inside the supply device transmitting a first controlsignal for activating the supply procedure to one of a plurality ofsupply units of the supply device if the first and the second datacorrespond at least in part.

A system of this type is advantageously characterized in that itprovides a high degree of reliability in the transfer of a preparedmedicament in a medicament container provided therefore to a respectivesupply device of a patient with respect to the correct allocation, sinceon account of using identification elements with the data attached to orin them a confusion of medicament containers of this type with themedicaments contained in them is no longer possible. On account ofreading and comparing different data, confusion of the medicaments is infact eliminated.

To this end, there is a first comparator unit inside the supply devicefor comparing the first and second data with respect to thecorrespondence of the data relating to the person. This means that theperson or the patient according to the first data, who has alreadyserved in the preparation of the medicament as the allocated person forthe medicament produced, can be compared with those data—relating to theperson—of the second data which can be taken from an armband or the likewhich is attached to the person. This ensures that the correctmedicament is allocated to the correct patient since otherwise thecontrol unit would not emit a release signal for activating the supplyprocedure. This means that the supply device, which can be an insulinpump, is not capable of being activated. The insulin pump for example isin fact capable of being activated only when it receives the correctmedicament with the associated medicament container, such as for examplea syringe, and establishes a correspondence of the data relating to theperson which are present on the syringe and on the patient.

A second comparator unit inside the supply device is provided forcomparing the data—relating to the medicament—of the first data with thesecond data relating to the medicament contained in a memory unit of thesupply device. This makes it possible for medicament compositionsalready saved in advance inside the memory unit of the supply device tobe compared with those compositions of the medicaments of the syringeused, so as to prevent incorrectly prepared medicaments with unrealisticmedicament compositions from being administered to the patient. In fact,for example, the second comparator unit of the supply device permits asupply procedure only when the first data—relating to the medicament—ofthe first data which are attached to the identification element of themedicament container are within a parameter or data range which has beensaved inside the memory unit as being permissible and suitable for thesecond data relating to the medicament. In this way, a patient isprevented from inadvertently receiving a medicament with a compositionwhich could lead to a further illness of the patient or could even leadto death. In this case too, a higher degree of reliability in theallocation of the correct medicament to each patient is provided.

Advantageously each composition of the previously prepared medicamentcan be conveyed automatically through the identification elementproduction device to the identification element, so as to ensure that noconstituents or portions of the composition are overlooked by theattending person.

In accordance with a preferred embodiment a selection unit of the supplydevice is provided for the selection at least in part of the firstand/or the second data relating to the medicament. This selection unitis intended to be used so that the correct data relating to themedicament is selected. To this end it is possible to resort either tofirst data relating to the medicament which are arranged on themedicament container by means of the identification element, or to thesecond data relating to the medicament which are saved inside the memoryunit of the supply device, in order optionally to select this moreadvantageous medicament composition. Alternatively, parameters of theselected second data relating to the medicament or of the selected firstdata relating to the medicament can be changed in order to be able toadminister an altered medicament composition with other dosages on thebasis of events which have occurred only recently.

In accordance with a preferred embodiment a blocking unit is providedfor blocking the start of a supply procedure on receipt of a secondcontrol signal of the control unit, the control unit sending this secondcontrol signal when the first and second data do not correspond at leastin part.

A blocking unit of this type has the aim that the continuation of theprocedure which is intended to start a supply procedure of a medicamentto the patient is not possible from the supply device, ifnon-corresponding data are established. This means that a stoppage ofthe procedure by the appliance automatically occurs if non-correspondingdata are established. As a result, a high degree of reliability shouldbe provided for a correct allocation of the medicament to the respectivepatient. In particular, if a large number of medicament allocations arepresent as a result of allocations of the medicament containers to thedifferent infusion pumps in different rooms of a hospital, the risk of awrong allocation of a medicament to the wrong patient is eliminated bythis, since the infusion pump or the supply device simply does notpermit such an administration of a medicament. Conclusion of theprocedure by means of the blocking unit is in fact achieved.

The identification element is advantageously a barcode label, a DataMatrix code label and/or a transponder. These labels can advantageouslybe secured by adhesion to the outer face of the medicament container, inwhich case the barcode label and the Data Matrix code label are printedout of the identification element production device and where atransponder is present the data are saved on the transponder by means ofa writer. This transponder can then be read out on the supply device bymeans of a reader, whereas the barcode label and the Data Matrix codelabel can be read out by means of a barcode scanner or a Data Matrixcode scanner.

It is advantageous for the supply device to be an insulin pump, thesupply unit to be one of a plurality of insulin pump units and themedicament container to be a syringe.

A method of administering medicaments to patients advantageously has thefollowing steps:

preparation of at least one liquid medicament in a mobile medicamentcontainer;

production of at least one first identification element with first datarelating to the person, medicament and/or treatment by means of anidentification element production device;

application of the identification element to the medicament container;

reading of the first data from or out of the first identificationelement by means of at least one reading device;

reading of second data, which are attached to or in a secondidentification element which is allocated to the patient;

comparison of the first and second data for correspondence at least inpart by means of a first comparator unit, and

activation of a supply procedure for supplying the medicament to thepatient with a supply device by means of a first control signal of acontrol unit to the supply device.

A method of this type allows the self-acting or automatic comparison ofread data in order to ensure that only when there is a correspondence ofthe read data is the procedure continued and so a supply procedure ofthe medicament to the patient is possible. This results in a high degreeof reliable allocation of the correct medicament to the correct patientin order to prevent the administration of wrong medicaments and thusfurther undesired symptoms of the patient.

In accordance with a preferred embodiment of the method according to theinvention it is provided in a step of reading third data which areattached to or in a third identification element which is allocated to aperson treating the patient that only the authorized attending person,i.e. a person from the clinical staff, will perform the administrationof the medicament with the correct allocation to the patient. Otherpersons thus have no access to the administration appliance whichconstitutes the supply device. As a result, a protection againstunauthorized actuation of the supply device and the supply ofmedicaments can be achieved.

In the same way, it is advantageous for a step of comparing firstdata—relating to the medicament—of the first data with second datarelating to the medicament saved in a memory unit of the supply deviceto be provided. In this step it is ensured that first data relating tothe medicament which are saved on the identification element arecompared with second data relating to the medicament saved in the memoryunit, and in this way it can be established whether the medicamentcomposition inside the medicament container corresponds to a permittedmedicament composition range within which the medicaments to beadministered are to lie.

Further advantageous embodiments are set out in the sub-claims.Advantages and expedient features may be seen in the followingdescription in conjunction with the drawing. In the drawing

FIG. 1 is a diagrammatic illustration of the system according to theinvention in accordance with an embodiment of the invention in itsfunctional sequence, and

FIGS. 2 a and 2 b show the method according to the invention inaccordance with an embodiment of the invention.

FIG. 1 is a diagrammatic illustration of the system—according to theinvention—of an embodiment of the invention. The medicament compositionwith the respective data relating to the person and the manner oftreatment is entered in a computer device 1 by the medical staff bymeans of a keyboard 2.

After that, a barcode 5 a which contains at least parts of the firstdata relating to the person, the medicament and/or the treatment isprinted inside an identification element production device 3 which ispresent in the form of a barcode printer. This barcode is printed out inthe form of a label and comprises for example a patient identificationnumber as data relating to the person, the name of the medicament andthe concentration thereof as data relating to the medicament, anddifferent dosage parameters, such as for example the duration of thedosage, as data relating to the treatment.

For example, the barcode label can have the inscription “Hans Müller”,“Adrenalin”, “2 mg/50” in addition to the barcode or the Data Matrixcode. This means that a dosage of 2 mg/50 for the medicament adrenalin,which is to be provided in a syringe 5, is present. At the same time themedicament is prepared in a composition in a medicament preparationstation 4 and is supplied to the syringe 5. After that or beforehand,the barcode 5 a is secured by adhesion to the syringe 5 by means of anadhesive surface.

After that, the barcode label 5 a is read out in a reading device 6 bymeans of a barcode scanner 7, as a result of which the data relating tothe person, the medicament and/or the treatment are read in inside asupply device 11.

At the same time a barcode, which is provided on an armband 10 of apatient 9 and likewise contains data relating to the person, is read outfrom this armband 10 by means of a further or the same barcode scanner8.

The data provided are then passed on to a first comparator unit 15 whichis preferably arranged inside the supply device 11. The comparator unit15 compares the data relating to the person, as provided on the armband10 by means of a barcode for example, with the data relating to theperson on the barcode label 5 a, as originally produced by the computerunit 1 with reference to the medicament produced by the medicamentpreparation station 4.

If correspondence of the data relating to the person, but alsooptionally of the data relating to the medicament, is established insidethe first comparator unit 15, an appropriate signal is passed on fromthe first comparator unit 15 to a control unit 16 which causes a firstcontrol signal 13 to be sent by means of a control line to the infusionsyringe 14 used, in order to actuate the supply unit 12 b forcompressing the syringe 14.

It should be noted in each case that different syringes, which containdifferent medicaments for administration to the patient, can be arrangedin different supply units 12 a, 12 b, 12 c, 12 d and 12 e. In this casethe syringe 14 is that syringe 5 which contains the medicament as hasbeen prepared beforehand.

If the first comparator unit establishes that there is no correspondencein the data relating to the person and optionally in the data relatingto the medicament, the control unit 16 will send an appropriate signalto a blocking unit 20 in order to effect a termination of the procedureand a blocking of the entire supply device 11 by means of this blockingunit. This ensures that the person is not allocated the wrongmedicament, since the medicament contains data relating to the personand the armband of the person 19 or of the patient 19 respectivelycontains data relating to the person which have to correspond thereto.

At the same time or in advance, third data which contain theperson-related data of a nurse are read in by means of the barcodescanner 7 or the barcode scanner 8 from an armband of the nurse. Thesethird data are used to compare the latter with permanently saved datawhich can be contained for example in a memory unit 19, in order toestablish that the nurse has authorized access for operating theappliance or this supply device 11. If it is established that otherperson-related data are involved here, for example since this nurse isnot authorized to administer insulin, then—in accordance with thesignals of a control unit—the <blocking unit 20> is in turn activatedand causes a conclusion of the procedure of the supply device 11.

Data—relating to the medicament—of the first data are compared withsecond data relating to the medicament which are contained in the memoryunit 19. This comparison is carried out inside a second comparator unit18. If it is established in a comparison of this type that there aredeviations between the first data relating to the medicament read in bymeans of the barcode scanner 7 and the second data relating to themedicament from the memory unit 19, or the first data are outside arange provided for the second data, then the user or the nurse is askedby means of a display unit and input unit 17 whether he or she stillwants to continue the treatment and which data he or she wants toimplement. As a result, the nurse can select the first data relating tothe medicament or the second data relating to the medicament in order tocontinue the treatment.

In addition or at the same time, the nurse can of course make a changeto the parameters on the supply device 11 by means of the display andinput unit 17, in order for example to change as a result the dosage ofthe medicament to be administered. This takes place in the constant dataexchange with the control unit 16 which subsequently in turn actuatesthe supply unit 12 b accordingly.

If the user or the nurse wishes to decide on one of the sets of data orthe first or second set of data relating to the medicament respectivelyduring a comparison by the second comparator unit 18, then anappropriate fault signal is sent by means of a selection unit 21 to thecontrol unit 16 which in turn actuates the supply unit 12 b with thesyringe 14 inserted therein in accordance with the selected data inorder to start the supply procedure or, where appropriate, to continueit.

After the administration of the medicament, which can be insulin forexample, has taken place, an automated documentation of theadministration parameters and the entire supply procedure as well as theentire sequence is in turn produced automatically, this preferably beingcarried out in the computer unit 1. This can be carried out by means ofwireless LAN for example as indicated by the arrow 22.

The method according to the invention is shown in accordance with anembodiment of the invention in FIGS. 2 a and 2 b.

In a step 25 the preparation of a medicament in accordance with theparameters and data entered is carried out. After that, in a step 26 anautomated formation of a barcode label for application to a medicamentcontainer is then carried out.

After that, in step 27 the attachment of the barcode label as an IDelement is then carried out by means of an adhesive surface for example.

After the syringe arrives at the supply device in the form of an insulinpump, a reading 28 of the first data which are contained on the barcodelabel, preferably encrypted, takes place. At the same time, a reading ofsecond data 29 which are present on an armband in the form of a barcodelabel, preferably encrypted, takes place.

A comparison is now carried out between the first and the second datafor the correspondence thereof in accordance with step 30, in order toeffect a conclusion of the entire procedure in the event ofnon-correspondence in accordance with step 31. If corresponding data, inparticular with respect to data relating to the person, are established,however, a reading 32 of third data takes place, which in a step 33 arein turn compared with data already saved in the insulin pump. These aredata on the attending person in order to establish whether this personis authorized for access. If this is negative, in a step 34 nopermission for treatment is allowed and termination takes place.

If, however, it is established that the nurse is authorized for accessand is authorized for treatment as the attending person, in a step 35first data relating to the medicament are compared for correspondencewith second data relating to the medicament. This is intended to ensurethat the data of the barcode relating to the medicament, as indicated onthe syringe, do not differ in an undesired manner from data rangesrelating to the medicament as provided which have already been savedinside the insulin pump. If a comparison of this type leads to a denialwith respect to the correspondence, in a step 36 a conclusion of theprocedure is carried out.

If an affirmative to this comparison is established in accordance withstep 35, a release signal is sent in a step 37 to one of the supplyunits and an activation of the supply procedure takes place. After that,a display of supply parameters is carried out in a step 38.

With renewed preparation in the event of a change in measured bloodglucose reference values in accordance with step 39 the cycle is startedfrom the beginning as shown by arrow 40.

Certain features disclosed in the application are understood to benovel, including for example, features either individually or incombination with other features as compared with the prior art.

LIST OF REFERENCE NUMERALS

-   1 computer device-   2 keyboard-   3 identification element production device-   4 medicament preparation station-   5 syringe-   5 a barcode-   6 reading device-   7 first barcode scanner-   8 further barcode scanner-   9 patient-   10 armband-   11 supply device-   12 a supply unit-   12 b supply unit-   12 c supply unit-   12 d supply unit-   12 e supply unit-   13 control signal-   14 infusion syringe-   15 comparator unit-   16 control unit-   17 input unit-   18 comparator unit-   19 memory unit-   20 blocking unit-   21 selection unit-   22 arrow-   25 preparation of the medicament-   26 production of the barcode label-   27 application of the barcode label-   28 reading of the first data-   29 reading of the second data-   20 comparison between the first and the second data-   31 conclusion of the entire procedure in the event of    non-correspondence-   32 reading of third data-   33 comparison of the third data with data already saved-   34 termination of the procedure on account of impermissibility of    the treatment-   35 comparison of the first data relating to the medicament with the    second ones-   36 conclusion of the procedure-   37 sending a release signal to one of the supply units-   38 display of the supply parameters-   39 renewed preparation in the event of a change in the measured    blood glucose values-   40 arrow—start of the cycle from the beginning

1. A system for administering medicaments to a patient, comprising: atleast one mobile medicament container with at least one liquidmedicament; an identification element production device for producing atleast one first identification element with first data relating to thepatient, medicament and/or treatment in order to attach it to themedicament container; at least one reading device for reading the firstdata from or out of the first identification element; at least onesupply device for supplying the medicament from the medicament containerinserted in the supply device to the patient; wherein the reading deviceis likewise suitable for reading second data, which are attached to orin a second identification element which is allocated to the patient,and is connected to the supply device, and a control unit inside thesupply device for transmitting a first control signal for activating asupply procedure to at least one of a plurality of supply units of thesupply device if the first and the second data correspond at least inpart.
 2. The system according to claim 1, further comprising a firstcomparator unit inside the supply device for comparing the first andsecond data with respect to the correspondence of the data relating tothe patient.
 3. The system according to claim 1, characterized furthercomprising a second comparator unit inside the supply device forcomparing the data—relating to the medicament—of the first data withsecond data relating to the medicament contained in a memory unit of thesupply device.
 4. The system according to claim 3, further comprising aselection unit of the supply device for the selection at least in partof the first and/or the second data relating to the medicament.
 5. Thesystem according to claim 1, further comprising a blocking unit forblocking the start of a supply procedure on receipt of a second controlsignal of the control unit, which is sent when the first and second datado not correspond at least in part.
 6. The system according to claim 1,wherein the first identification element is a barcode label, a DataMatrix code label and/or a transponder.
 7. The system according to claim1, wherein the supply device is an insulin pump, the supply unit is oneof a plurality of insulin pump units and the medicament container is asyringe.
 8. A method for administering medicaments to patients, with thefollowing steps: preparation of at least one liquid medicament in amobile medicament container; production of at least one firstidentification element with first data relating to the patient,medicament and/or treatment by means of an identification elementproduction device; application of the identification element to themedicament container; reading of the first data from or out of the firstidentification element by means of at least one reading device; readingof second data, which are attached to or in a second identificationelement which is allocated to the patient; comparison of the first andsecond data for correspondence at least in part by means of a firstcomparator unit, and activation of a supply procedure for supplying themedicament to the patient with a supply device by means of a firstcontrol signal of a control unit to the supply device.
 9. The methodaccording to claim 8, further comprising a step of reading third datawhich are attached to or in a third identification element which isallocated to a person treating the patient.
 10. The method according toclaim 8, further comprising a step of comparing first data—relating tothe medicament—of the data with second data relating to the medicamentsaved in a memory unit of the supply device.